Protocol summary
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Study aim
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A comparative study of the effect of traditional and simulation training methods on the correct technique of inhalation drug use in nursing students
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Design
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In this study, a clinical trial with a control group, with parallel groups, double-blind, randomized, the samples were assigned to the intervention and control groups based on simple random sampling. The sample size was calculated for each group of 39 people.
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Settings and conduct
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Each group was given 20 minutes to practice the technique of using the devices in a group and then to be evaluated among their peers. Students in the intervention group have 5 minutes to teach the simulated patient and The rest of the students will observe the patient counseling process until the patient completes all the steps correctly. Patients in the study will act on scenarios pre-designed by the researcher. So that in each performance, the patient will intentionally perform one or more steps of the technique based on the developed scenario, and the student must identify and correct the incorrect technique to the patient.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Satisfaction to participate in the study; Do not participate in other classes and educational programs; Lack of experience and work experience of students from the inhaled devices in the hospital or outside it, (except internship)
Exclusion criteria: Having a degree from another field;The student's personal experience in using inhalers for himself or a family member
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Intervention groups
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The training control group will use the traditional method and the intervention group (simulation) will use simulated scenarios and counseling with the simulated real patient.
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Main outcome variables
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The correct technique of using inhaled drugs that was done before the intervention and one week after the intervention and based on the checklist.
General information
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Reason for update
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Due to the Covide- 19 pandemic and changes in student curricula, the start and end dates of sampling were changed
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Acronym
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.
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IRCT registration information
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IRCT registration number:
IRCT20120409009422N10
Registration date:
2021-02-28, 1399/12/10
Registration timing:
prospective
Last update:
2022-01-03, 1400/10/13
Update count:
1
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Registration date
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2021-02-28, 1399/12/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-11-10, 1399/08/20
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Expected recruitment end date
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2020-12-10, 1399/09/20
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Actual recruitment start date
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2021-03-05, 1399/12/15
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Actual recruitment end date
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2021-04-10, 1400/01/21
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Trial completion date
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2021-04-10, 1400/01/21
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Scientific title
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A comparative study of the effect of traditional and simulation training methods on the correct technique of inhalation drug use in nursing students
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Public title
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Effect of traditional and simulation training methods on the correct technique of inhalation drug use
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Satisfaction to participate in the study
Do not participate in other classes and educational programs
Lack of experience and work experience of students from the inhaled devices in the hospital or outside, (except internship)
Exclusion criteria:
Having a degree from another field
The student's personal experience in using inhalers for himself or a family member
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
80
Actual sample size reached:
81
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, after coordination with the director of the relevant group, 81 nursing students of the 4th and 5th semesters of nursing in the first semester of 1399 will be included in the study as a census based on the inclusion and exclusion criteria. 4th and 5th semester students According to the grouping, the nursing group manager will be divided into 11 groups (minimum 4 to maximum 10 people). Then, out of these 11 groups, six groups will be randomly assigned to the simulation group (intervention) and five groups to the traditional group (control) using luck coins. Therefore, the randomization method is simple and group randomization unit.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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In this study, only the person evaluating the outcome and the person analyzing the data are blind, and the participants in this study are not blind, and in this sense it is a one-sided blind study.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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.
Ethics committees
1
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Ethics committee
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Approval date
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2020-09-16, 1399/06/26
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Ethics committee reference number
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IR.UMSU.REC.1399.203
Health conditions studied
1
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Description of health condition studied
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The correct technique of inhalation drug use
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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The correct technique of inhalation drug use
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Timepoint
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Before the intervention and one week after the intervention
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Method of measurement
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Checklist consisting of professional standards related to the correct technique of using inhaled drugs
Intervention groups
1
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Description
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Control group: In this group, training will be given in the traditional way (lecture with slide show) and practical training, with evaluation / training by peers.
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Category
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N/A
2
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Description
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Intervention group:In this group (simulation) in addition to practical training, simulated scenarios and simulated real patient counseling will be used with peer assessment / training.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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.
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Oroumia University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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.
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available